Monsanto Co. v. Office of Envtl. Health Hazard Assessment

22 Cal.App.5th 534

231 Cal.Rptr.3d 537

MONSANTO COMPANY, Plaintiff and Appellant,

v.OFFICE OF ENVIRONMENTAL HEALTH HAZARD ASSESSMENT et al., Defendants and Respondents;

California Citrus Mutual et al., Interveners and Appellants;

Center for Food Safety et al., Interveners and Respondents.

F075362

Court of Appeal, Fifth District, California.

Filed April 19, 2018

Arnold & Porter Kaye Scholer, Trenton H. Norris, Sarah Esmaili and S. Zachary Fayne, San Francisco for Plaintiff and Appellant.

Law Office of Peg Carew Toledo and Peg Carew Toledo, Roseville for California Chamber of Commerce and Civil Justice Association of California; Gregory Herbers for Washington Legal Foundation as Amici Curiae on behalf of Plaintiff and Appellant.

Kahn, Soares & Conway, George H. Soares, Sacramento, Ann M. Grottveit, Hanford and Carly A. Cardenas for Interveners and Appellants California Citrus Mutual, Western Agricultural Processors Association, California Cotton Ginners and Growers Association, California Grain and Feed Association, Almond Alliance of California, and Western Plant Health Association.

Xavier Becerra, Attorney General, Susan S. Fiering, Dennis A. Ragen, Heather C. Leslie and Laura J. Zuckerman, Deputy Attorneys General, for Defendants and Respondents.

Selena Kyle; Altschuler Berzon, Stephen P. Berzon, Jonathan Weissglass and Connie K. Chan, San Francisco; James R. Wheaton, Oakland, Lowell Chow, Nathaniel Kane; Adam F. Keats, Joshua Tree and Ryan Berghoff, San Francisco for Interveners and Respondents Sierra Club, Natural Resources Defense Council, United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, Environmental Law Foundation and Center for Food Safety.

HILL, P.J.

Appellants,¹ led by Monsanto Company and including intervenors California Citrus Mutual, Western Agricultural Processors Association, California Cotton Ginners and Growers Association, California Grain and Feed Association, Almond Alliance of California, and Western Plant Health Association, appeal from a trial court order and judgment dismissing appellants' petition for writ of mandate and complaint. They are supported by amicus briefing from the California Chamber of Commerce and Civil Justice Association of California, as well as from the Washington Legal Foundation. Respondents consist of the Office of Environmental Health Hazard Assessment (Office) and its director, Lauren Zeise, in her official capacity, along with intervenors Sierra Club; Center for Food Safety; National Resources Defense Council; Environmental Law Foundation; and United Steel, Paper and Forestry, Rubber Manufacturing, Energy, Allied Industrial and Service Workers International Union, AFL-CIO, CLC.

At the heart of this case is a singular assertion. Appellants believe it is improper for a foreign entity, unaccountable to the citizens of California, to determine what chemicals are known to the state to cause cancer. In opposition, respondents contend the electorate has already decided the state should not be the sole entity to identify potential carcinogens and have, within the bounds of the law, chosen to rely on the pre-existing and continuing work of an internationally recognized and world-government funded entity to identify potential carcinogens. Within the framework of these positions, we are tasked with considering whether Proposition 65's reliance on the International Agency for Research on Cancer (the Agency) to identify known carcinogens violates various provisions and doctrines of the California and United States Constitutions. Below, the trial court concluded appellants had failed to state a claim under any of the theories they pursued. For the reasons set forth below, we affirm.

FACTUAL AND PROCEDURAL BACKGROUND

This case reaches us following the trial court's decision to grant a demurrer and motion for judgment on the pleadings. As such, the factual record in this case is limited. We note this at the outset to clarify that the following facts are generally taken from the operative complaint. To the extent background information regarding the relevant statutory or regulatory schemes is relevant, such information is provided in our discussion of the issues arising in this case.

According to the complaint, glyphosate is a widely used herbicide manufactured and marketed by Monsanto. Most people would likely recognize it from Monsanto's Roundup product line, although the chemical is registered for use in more than 160 countries.

Since its introduction in 1974, glyphosate has been studied multiple times and by multiple groups to determine its potential as a carcinogen. Regulatory bodies reviewing these studies include the Environmental Protection Agency, the German Federal Institute for Risk Assessment, the European Food Safety Authority, the European Commission, and the Canadian Pest Management Regulatory Authority. Prior to the instant case, these groups have uniformly failed to identify glyphosate as carcinogenic. The Office itself conducted two different risk assessments for glyphosate, in 1997 and 2007. In both instances, Office staff members and scientists reviewed several carcinogenicity studies involving animals and concluded there was no evidence that glyphosate causes cancer.

In 2014, the Agency undertook its own review of the carcinogenicity of glyphosate. The Agency "is a specialized cancer agency of the WHO [World Health Organization] that is based in Lyon, France." It is funded by the governments of 25 countries, including the United States, as well as by grants.

One of the Agency's activities involves the publication of Monographs. Monographs review and summarize scientific research on the carcinogenicity of various chemicals. In conducting these studies, the Agency's focus is upon cancer hazards, " ‘even when risks are very low at current exposure levels.’ " In other words, Monographs review whether an agent is capable of causing cancer but do not consider the likelihood cancer will occur.

The Agency creates its Monographs through working groups. Working groups are made up of between 10 and 30 Agency-selected private sector scientists that are knowledgeable about one or more of the chemicals under review. These working groups then review a specified type of scientific data—roughly summarized as published scientific studies and publicly available government data—and ultimately classify the reviewed chemicals. These classifications include: carcinogenic to humans (Group 1), probably carcinogenic to humans (Group 2A), possibly carcinogenic to humans (Group 2B), not classifiable as to its carcinogenicity to humans (Group 3), and probably not carcinogenic to humans (Group 4.) The data relied upon to make these classifications is further categorized as "sufficient evidence of carcinogenicity; limited evidence of carcinogenicity; inadequate evidence of carcinogenicity; and evidence suggesting lack of carcinogenicity." According to the complaint, there are several alleged errors in the processes and procedures utilized to form working groups and under which the working groups operate.

With respect to glyphosate, a group of 17 scientists reviewed published literature and concluded glyphosate was " ‘probably carcinogenic to humans' (Group 2A)." This determination was based on findings in four specific animal studies that the working group concluded showed sufficient evidence of carcinogenicity. Each of these studies or a summary thereof were specifically reviewed by the Office when it had previously concluded that glyphosate is " ‘unlikely to pose a cancer hazard to humans.’ " Moreover, according to appellants, these studies had been reviewed in the course of 17 different analyses by other groups, all of which reached the opposite conclusion reviewing the data, "namely, that the small number of tumors observed in rodents subjected to treatment with glyphosate in these studies were not related to glyphosate." Regardless of this conflict, the Agency's determination was published in a 2015 Monograph.

Following publication of the 2015 Monograph, the Office published a "Notice of Intent to List" glyphosate as a substance known to the state to cause cancer under the requirements of Proposition 65. Under the law and its regulations, the Office concluded the 2015 Monograph publication brought glyphosate within the listing requirements. As the Office stated, " ‘Because these are ministerial listings, comments should be limited to whether [the Agency] has identified the specific chemical or substance as a known or potential human or animal carcinogen. Under this listing mechanism, [the Office] cannot consider scientific arguments concerning the weight or quality of the evidence considered by [the Agency] when it identified these chemicals and will not respond to such comments if they are submitted.’ "

In January 2016, appellants responded, in part, by filing a petition for writ of mandate and complaint for preliminary and permanent injunctive and declaratory relief to stop this listing determination. They subsequently filed a first amended complaint, which remains the operative pleading. Respondents filed a motion for judgment on the pleadings and demurrer to the complaint. Following briefing and argument, the trial court granted the motion for judgment on the pleadings and sustained the demurrer, finding appellants had not stated facts sufficient to support any asserted claims against respondents.

This appeal timely followed.

DISCUSSION

As briefly alluded to above, this case is essentially a series of attacks on a specific aspect of Proposition 65, its reliance on Labor Code section 6382, subdivision (b)(1), to identify chemicals known to the state to cause cancer. Consistent with the briefing, we will refer to this mechanism as the Labor Code listing mechanism.² Accordingly, a brief overview of Proposition 65 and its incorporation of a portion of the Labor Code will help to clarify the framework within which this opinion...